The present invention consists of a method to accurately locate and to precisely remove soft tissue specimens in human biopsy operations.
In the diagnosis and treatment of tumors and particularly in the treatment of breast cancer in females, it is of great importance to locate and treat malignancies at their earliest stage of growth. Such early tumors are detected by the presence of minute, x-ray opaque deposits known as microcalcifications. In the present state of the art women are encouraged to routinely submit themselves for examination by radiography techniques. These examinations detect the minute deposits which can indicate the presence of early cancer. In the event that such deposits are found, a biopsy is advised to determine if cancer actually exists. About one in ten of these biopsies are positive.
The major technical problem in biopsy is difficulty in locating the area in the breast shown on the x-ray because the lesions are usually small and cannot be felt by the surgeon. Attempts have been made to mark the location of observed deposits on a chart or to inject a dye into the area containing the lesions. The dye, however, tends to diffuse into adjacent tissue in a short time and is, therefore, of limited value.
In consequence of the limited and inaccurate means of marking the suspected tumor location and, additionally, because of the dimensionally unstable character of breast tissue, a surgeon will remove substantial quantities of breast tissue to insure that he obtains the area of suspected malignancy. Even then, subsequent examination of the removed tissue may reveal the biopsy was not well located and a second biopsy may be required. Such biopsy procedures result in undue physical deformity and increase surgical morbidity.